Search Results
Found 1 results
510(k) Data Aggregation
(104 days)
NXSTAGE SYSTEM ONE WITH NXVIEW
NxStage System One: The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment. All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. NxView: NxView is a computer-based touch screen user interface that provides on-line instructions for use, summarized system information and remote access. NxView is contraindicated as the sole method of monitoring a patient during treatment.
The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler: and NxView, a flat panel touch screen interface which is mounted on top of the cycler and provides online instructions for use, summarized system information, and remote viewing of treatment information. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One with NxView is also indicated for Therapeutic Plasma Exchange in a clinical environment.
The provided text describes a 510(k) premarket notification for the "NxStage System One with NxView," a hemodialysis system. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to showcase a new device's performance against detailed acceptance criteria using a study.
Therefore, much of the requested information regarding acceptance criteria and performance studies (like sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) is not applicable or not available in this document.
However, I can extract information related to the device's technical characteristics and how its performance is compared to the predicate device.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating that the "NxStage System One with NxView" has the same technological characteristics or comparable specifications to its predicate device (NxStage System One (K122051)). Therefore, the "acceptance criteria" are implicitly defined by the predicate device's established performance and specifications. The "reported device performance" for the proposed device is its sameness or similarity to these predicate specifications.
| Parameter | Predicate Device (K122051) Specification/Performance (Implicit Acceptance Criteria for Proposed Device) | Proposed Device (NxStage System One with NxView) Performance |
|---|---|---|
| Intended Use | Hemodialysis, Hemofiltration, Ultrafiltration | Yes (Same) |
| Pumps | 4 peristaltic pumps | Same |
| Valves (Clamps) | 2 solenoid actuated pinch clamps, 8 cam driven pinch clamps | Same |
| Air / fluid detectors | 3 ultrasonic air/ fluid detectors | Same |
| Blood leak detector | 1 optical blood leak detector | Same |
| Pressure transducers | 5 electronic pressure transducers | Same |
| Temperature sensors | 1 electronic temperature sensor | Same |
| Blood Flow Rates | 10-600 ml/min | Same |
| Prescription Fluid /Dialysate Flow | 0-12000 ml/hr (NX1000-1 & NX1000-2), 0-18000 ml/hr (NX1000-3) | 0-12000 ml/hr (NX1000-5) - Note: This is a specific model reference in the proposed device, while the predicate lists multiple models/ranges. Implies general equivalence within range. |
| Ultrafiltration | 0-2400 ml/hr | Same |
| Transmembrane Pressure Monitoring | Yes | Same |
| Venous Pressure Monitor | 0 to 400 mmHg | Same |
| Effluent fluid Pressure Monitor | 0 to 500 mmHg | Same |
| Air Detector | Reduction of detector signal lasting 6 ms minimum (Approximates a 60 microliter bubble at 400 mmHg venous pressure and 600 ml/min blood flow) | Same |
| Blood Leak Detector | 15% reduction in detector signal lasting 20 seconds minimum (based on a 0.45 ml/min leak rate of 32 Hct blood) | 15% reduction in detector signal lasting 20 seconds minimum (based on a 0.35 ml/min leak rate of 32 Hct blood) - Note: Proposed device states a lower leak rate for the same signal reduction, implying potentially better or at least equivalent detection. |
| Effluent Volume Accuracy | Greater of 300 ml/ 12 hr or 3% of exchange volume (for software versions 4.7 and below); For software versions 4.8 and higher: Therapy Fluid Flow Rate L/hr) Specification greater of > 3 ±100 ml/hr* or + 5% UF*; ≤ 3 ± 25 ml/hr* (*Representing 95/90 tolerance interval established under controlled laboratory testing conditions.) | Same (refers to same complex specification as predicate) |
| IV Prescription Fluid | Off-line, sterile- physician prescribed, indicated for infusion | Same |
| Dialysate | Available as pre-packaged pre-mixed sterile fluids or via the PureFlow SL | Same |
| Compatible Blood Tubing Set | NxStage Standard Cartridge | Same |
| Software | Software version 4.8 | Software version 4.9 |
| NxView (Interface) | OneView (K040074) touch screen interface is an optional accessory | NxView touch screen interface included as standard with NxStage System One |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The document refers to "Performance, verification and validation testing" (G. Summary of Non-Clinical Test/Performance Testing - Bench) to characterize the proposed device. However, specific sample sizes, study designs, or data provenance (e.g., country of origin, retrospective/prospective) for this testing are not detailed. It is bench testing, suggesting in-lab rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnoses). This submission is for a hemodialysis system based on technological characteristics and bench testing.
4. Adjudication method for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-based diagnostic device undergoing human-in-the-loop evaluation. The NxView is a user interface, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not in the context of an "algorithm-only" performance for diagnostic accuracy. The "testing" mentioned is to verify the hardware and software functionality of the hemodialysis system against engineering specifications.
7. The type of ground truth used
- For the non-clinical testing ("bench testing"), the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device and internal design requirements. The device's performance observed in testing was compared against these predefined physical and functional benchmarks.
8. The sample size for the training set
- Not applicable. This submission describes a medical device, not a machine learning model that undergoes "training."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Ask a specific question about this device
Page 1 of 1